Adenoviruses (AdVs) of the genus Mastadenovirus have been examined as anticancer agents (Huebner, R. J., Rower W. P., Schatten, W. E., Smith, R. R, & Thomas, L. B. (1956). Studies on the use of viruses in the treatment of carcinoma of the cervix. Cancer 9(6), 1211-1218; Cody, J. J. & Douglas, J. T. (2009). Armed replicating adenoviruses for cancer virotherapy. Cancer Gene Ther 16, 473-488; Yamamoto, M. & Curiel, D. T. (2010). Current issues and future directions of oncolytic adenoviruses. Mol Ther 18, 243-250.) and vaccine vectors (Lasaro, M. O. & Ertl, H. C. J. (2009). New Insights on Adenovirus as Vaccine Vectors. Molecular Therapy 17, 1333-1339.). The problem of preexisting immunity against HAdV-5, exemplified in the STEP HIV trial that employed recombinant HAdV-5 (Buchbinder, S. P., Mehrotra, D. V., Duerr, A., Fitzgerald, D. W., Mogg, R., Li, D., Gilbert, P. B., Lama, J. R., Marmor, M. & other authors. (2008). Efficacy assessment of a cell-mediated immunity HIV-1 vaccine (the Step Study): a double-blind, randomised, placebo-controlled, test-of-concept trial. Lancet 372, 1881-1893; McElrath, M. J., De Rosa, S. C., Moodie, Z., Dubey, S., Kierstead, L., Janes, H., Defawe, O. D., Carter, D. K., Hural, J. & other authors. (2008). HIV-1 vaccine-induced immunity in the test-of-concept Step Study: a case-cohort analysis. Lancet 372, 1894-1905), has generated interest in the development of less common AdV serotypes and nonhuman AdVs as both oncolytic (Cody & Douglas, 2009; Gallo, P., Dharmapuri, S., Cipriani, B. & Monaci, P. (2005). Adenovirus as vehicle for anticancer genetic immunotherapy. Gene Ther 12, S84-S91; Shashkova, E. V., Cherenova, L. V., Kazansky, D. B. & Doronin, K. (2005). Avian adenovirus vector CELO-TK displays anticancer activity in human cancer cells and suppresses established murine melanoma tumors. Cancer Gene Ther 12, 617-626) and vaccine vectors (Barouch, D. H. (2008). Challenges in the development of an HIV-1 vaccine. Nature 455, 613-619; Lasaro & Ertl, 2009; Sharma, A., Tandon, M., Ahi, Y. S., Bangari, D. S., Vemulapalli, R. & Mittal, S. K. (2009). Evaluation of Cross-Reactive Humoral and Cell-Mediated Immune Responses among Human, Bovine and Porcine Adenoviruses. Molecular Therapy 17, 113). Fowl adenoviruses (FAdVs) of the genus Aviadenovirus, including species FAdV-A to FAdV-E (Adair, B. & Fitzgerald, S. (2008). Group I Adenovirus Infections. In Diseases of Poultry, 12th ed, pp. 252-266. Edited by Y. Saif, A. Fadly, J. Glisson, L. McDougald, L. Nolan & D. Swayne. Hoboken, N. J.: Wiley-Blackwell; Benkö, M., Harrach, B., Both, G., Russell, W., Adair, B., Ádam, É., de Jong, J., Hess, M., Johnson, M. & other authors. (2005). Family Adenoviridae. In Virus taxonomy Eighth report of the International Committee on the Taxonomy of Viruses, pp. 213-228. Edited by C. Fauquet, M. Mayo, J. Maniloff, U. Desselberger & L. Ball. San Diego, Calif.: Elsevier Academic Press.), are being developed as vaccine vectors. The first generation of FAdV-based vaccine vectors have proven effective at eliciting an antibody response against a delivered transgene (Corredor, J. C. & Nagy, E. (2010b). The non-essential left end region of the fowl adenovirus 9 genome is suitable for foreign gene insertion/replacement. Virus Res 149, 167-174; Ojkic, D. & Nagy, E. (2003). Antibody response and virus tissue distribution in chickens inoculated with wild-type and recombinant fowl adenoviruses. Vaccine 22, 42-48.), and in chickens have conferred protective immunity against infectious bursal disease virus (IBDV) (Francois, A., Chevalier, C., Delmas, B., Eterradossi, N., Toquin, D., Rivallan, G. H. & Langlois, P. (2004). Avian adenovirus CELO recombinants expressing VP2 of infectious bursal disease virus induce protection against bursal disease in chickens. Vaccine 22, 2351-2360; Sheppard, M., Werner, W., Tsatas, E., McCoy, R., Prowse, S. & Johnson, M. (1998). Fowl adenovirus recombinant expressing VP2 of infectious bursal disease virus induces protective immunity against bursal disease. Arch Virol 143, 915-930) and infectious bronchitis virus (Johnson, M. A., Pooley, C., Ignjatovic, J. & Tyack, S. G. (2003). A recombinant fowl adenovirus expressing the S1 gene of infectious bronchitis virus protects against challenge with infectious bronchitis virus. Vaccine 21, 2730-2736.). Analysis of the complete genomes of FAdV-1, the chicken embryo lethal orphan (CELO) virus Chiocca, S., Kurzbauer, R., Schaffner, G., Baker, A., Mautner, V. & Cotten, M. (1996). The complete DNA sequence and genomic organization of the avian adenovirus CELO. J Virol 70, 2939-2949.), and FAdV-9 (Ojkic, D. & Nagy, E. (2000). The complete nucleotide sequence of fowl adenovirus type 8. J Gen Virol 81, 1833-1837.) (species FAdV-A and FAdV-D, respectively), and the terminal genomic regions of FAdV-2, -4, -10, and -8 Corredor, J. C., Garceac, A., Krell, P. J. & Nagy, E. (2008). Sequence comparison of the right end of fowl adenovirus genomes. Virus genes 36, 331-344; Corredor, J. C., Krell, P. J. & Nagy, E. (2006). Sequence analysis of the left end of fowl adenovirus genomes. Virus genes 33, 95-106.) has shown that the FAdVs share a common genome organization.
Adenovirus-based veterinary vaccine vectors have proven to be promising tools for controlling veterinary pathogens (Bangari, D. S. & Mittal, S. K. (2006). Development of nonhuman adenoviruses as vaccine vectors. Vaccine 24, 849-862; Ferreira, T. B., Alves, P. M., Aunins, J. G. & Carrondo, M. J. T. (2005). Use of adenoviral vectors as veterinary vaccines. Gene Ther 12, S73-S83). The first generation of fowl adenovirus (FAdV) based vaccine vectors have been effectively used to induce an antibody response against an inserted foreign gene (transgene) (Corredor, J. C. & Nagy, E. (2010a). A region at the left end of the fowl adenovirus 9 genome that is non-essential in vitro has consequences in vivo. J Gen Virol 91(1), 51-58; Ojkic & Nagy, 2003), and in chickens have conferred protective immunity against infectious bursal disease virus (Francois et al., 2004; Sheppard et al., 1998) and infectious bronchitis virus (Johnson et al., 2003).
The use of adenovirus as vectors is described in International Publication No. WO 2003/039593, which discloses an attenuated serotype 4 fowl adenovirus (FAV 4) having a deletion of about 2-3 kb and which is able to produce a cytopathic effect in cells of a QT 35 cell line and to induce protective immunity in birds, in contrast to an inactivated FAV 4 and a live natural a-pathogenic FAV 4, which show a poor immunogenicity. This virus can be used as well as a vector to heterologous nucleic acid fragments encoding for a polypeptide, allowing the immunisation of animals against FAV and other avian pathogens.
In U.S. Pat. No. 6,296,852 there is described a recombinant vector comprising a recombinant avian adenovirus which incorporates at least one heterologous nucleotide sequence, which is inserted into a non-essential region at the right hand end of the genome of the avian adenovirus between map units 60 and 100, the avian adenovirus being selected from serotypes 4, 8, 9 and 10.
Additionally, US Patent Application No. 2010/0150958 describes a coccidiosis vaccine comprising a recombinant avian adenovirus vector having a promoter operably linked to a hydrophobic signal sequence comprising a nucleic acid that encodes a membrane anchoring domain, a multiple cloning site for insertion of an ORF to allow insertion of an ORF in frame with said hydrophobic signal sequence, a polyadenylation signal; and an avian adenovirus genome. The avian adenovirus genome is selected from serotypes 1 to 12.
US Patent Application No. US 2010/0158939 discloses adenovirus vectors, human and non-human, containing polynucleotide sequences that encode one or more influenza antigens. Among the adenovirus suitable for being used as vectors, there are included several serotypes (1 to 10) of avain adenovirus, which are available in the ATCC.
Accordingly, it can be seen from the above that, even when there are several serotypes of avian adenoviruses used as viral vectors, there is a need for new adenoviruses having better characteristics, such as a high replication, that can be used to prepare viral vectors useful for immunogenic applications.